Proteinase K Market (By Form: Powder, Liquid; By Therapeutic Area: Infectious Diseases, Neurology, Oncology; By Application; By End Use) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2022-2030

The global proteinase K market was surpassed at USD 3.7 billion in 2021 and is expected to hit around USD 7.98 billion by 2030, growing at a CAGR of 8.92% from 2022 to 2030.

Report Highlights

• The powder segment accounted for the largest share of over 50.05% in 2021.
• The infectious diseases segment captured the largest share of over 30.1% in 2021. 
• The neurology segment is predicted to expand at an exponential CAGR of 9.62% during the forecast period. 
• The biotechnology companies segment accounted for the largest share of over 35.06% in 2021. 
• The isolation and purification of genomic DNA and RNA segments held the largest share of over 55.03% in 2021. 
• North America captured the largest share of over 45.21% in 2021.
• Asia Pacific is expected to grow at the fastest rate of 11.5% from 2022 to 2030.

The market growth is fueled by a broad range of applications in molecular diagnostic techniques and their associated enzymes for IVD. Proteinase K can be utilized as a supplement in PCR and NGS. Increasing applications of NGS in personalized medicine along with various clinically developed therapies are likely to favor the market for proteinase K. Gene expression profiling and targeted panels via qPCR remain the two most frequent uses for NGS sequences in a pathology lab. In addition, a decline in the price of NGS sequencing has expanded the use of NSC technologies. Therefore, the growing demand for NGS diagnostic techniques is expected to boost the market growth.

In addition, the rising adoption of cell separation procedures is one of the major factors contributing to the market growth. Companies have initiated building sustainable technologies to gain a competitive edge in the market. For instance, in April 2022, Levitas Bio introduced the next generation of its existing platform for cell separation. The new version is expected to assist researchers in scaling their experiments up to 16X and process around 40 million cells per run.

Moreover, the usage of POC-based diagnostics is increasing significantly globally. Public awareness campaigns aimed at identifying the symptoms of infectious diseases and ways to prevent them play an important role in controlling disease transmission. Thus, increased patient attention has led to a rise in demand for POC. For instance, in May 2020, a study on POC testing for COVID-19 through Specific High Sensitivity Enzymatic Reporter UnLOCKing (SHERLOCK) diagnostics was published. The researchers used QuickExtract by Lucigen, which contains Proteinase K. Thus, the growing demand for POC diagnostics and the utility of proteinase K in POC diagnostic tests are expected to fuel market growth.

Furthermore, growing applications of proteinase K in molecular biology and other fields are expected to create lucrative opportunities in the near future. Proteinase K is used in the food and beverage industry to maintain quality standards. Food manufacturers work to maintain the quality of raw materials used for manufacturing. In addition, proteinase K is used for cell lysis during DNA extraction from processed foods. The enzyme also finds application in a wide range of molecular biology assays. Hence, such applications of proteinase K are anticipated to drive the market during the forecast period.

Scope of The Report

Form Insights

The powder segment accounted for the largest share of over 50.05% in 2021 owing to the benefits offered by the technique. The powder form of proteinase K is ready to use and has numerous advantages such as long shelf-life, inexpensive shipment, and high stability. In addition, powder form does not reduce the activity of proteinase K and is stable to transport through the ship with no prerequisite in terms of temperature conditions, thus cutting down the extra cost for ice-pack shipment. Thus, the advantages of powder form are increasing its applications, thereby contributing to the market growth.

The liquid segment is expected to grow at the fastest rate over the forecast period. Under various circumstances, the liquid form of proteinase K is preferred over the powdered form. The liquid form is relatively more convenient to boil down. In addition, it is a time saver as the solution is ready to use and thus no time is required for solubilizing. Importantly, there is a lower risk of contaminating proteinase K, which would harm the RNA or DNA samples. Therefore, such advantages of liquid form aid in the large batch production, which is expected to fuel the market growth during the forecast period.

Therapeutic Area Insights

The infectious diseases segment captured the largest share of over 30.1% in 2021. The increasing incidence of infectious diseases such as HIV, tuberculosis, and malaria in low- to mid-income countries is anticipated to encourage players to develop products that are easy to operate in a low-resource setting. For instance, QIAGEN offers QIAGEN Proteinase K, which is isolated from the saprophytic fungus Tritirachium album, and it is a subtilisin-type protease. The product is used in the isolation of DNA and RNA from the samples during the diagnosis of viral and bacterial infection. Hence, the presence of proteinase K in rapid molecule testing is expected to accelerate market growth.

The neurology segment is predicted to expand at an exponential CAGR of 9.62% during the forecast period. Various therapies for neurology are under development such as small molecule therapies, enzyme replacement, gene editing, splicing, and gene-replacement therapies with adeno-associated vectors. In addition, gene expression profiling is considered to be an important tool for identifying diagnostic and therapeutic targets in neurological diseases. Proteinase K is used during the extraction process as it enhances the RNA yield and makes the majority of samples eligible for array analysis. Innovation in therapies is one of the key drivers for the market.

End-use Insights

The biotechnology companies segment accounted for the largest share of over 35.06% in 2021. This is due to an increase in the application of in situ hybridization (ISH) techniques to support clinical and preclinical studies for biotechnology companies is expected to drive the segment. ISH staining, tissue sectioning, high-resolution full-slide scanning, scoring, and image analysis are ISH protocols implemented by these entities. Implementation of ISH protocols fuels the usage of a proteinase K enzyme that is used for the digestion of tissue samples during ISH.

The academic institutes' segment is expected to witness the fastest growth during the forecast period. Academic laboratories offer integrated services for every stage of IVD clinical research, ranging from its development to commercialization. In addition, several collaborations for the development of new technologies with other academic and industrial agencies for the development of clinical trial procedures, such as expert review of biopsy histopathology or cytology. Such reviewing of histology assays by academic laboratories involves the usage of proteinase K enzyme for the digestion of tissue samples, thereby driving its usage rate in academic laboratories.

Application Insights

The isolation and purification of genomic DNA and RNA segments held the largest share of over 55.03% in 2021. Proteinase K is used at multi-stages in the process of genomic DNA and RNA purification. Before initiating the process, it is stored at -20°C. Under the stage of sample lysis, it is used for cultured cells, mammalian whole blood (non-nucleated), animal tissue, and nucleated whole blood. The isolation and purification of genomic DNA and RNA have become a routine process in CROs and biotechnology companies. With the emerging need for personalized treatment in cancer and rare diseases, the demand for DNA or RNA isolation is anticipated to witness upward trends and similar trends will be reflected in the market.

The in situ hybridization segment is expected to expand at a lucrative CAGR during the forecast period. The increasing adoption can be attributed to associated benefits such as high-volume testing and the presence of automated devices equipped to facilitate tests with greater speed and accuracy. The increasing incidence of diseases associated with chromosomal aberrations such as genetic abnormalities and cancer, coupled with unmet diagnostic and clinical needs, is expected to be a high growth-rendering factor for this segment.

Regional Insights

North America captured the largest share of over 45.21% in 2021 owing to the high demand for proteinase K and the increasing prevalence of infectious disorders in the region. To combat the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUA) for in vitro COVID-19 laboratory-developed tests. In addition, most of these EUAs have been for enzyme-linked immunosorbent assay and reverse transcription polymerase chain reaction (RT-PCR)-based tests for the detection of SARS-CoV-2. Owing to the high applications of enzymes during RT-PCR, the development of such tests is expected to help generate revenue in the North American market.

Asia Pacific is expected to grow at the fastest rate of 11.5% from 2022 to 2030 owing to increasing applications of sequencing technology, coupled with various government initiatives to promote genomics research and precision medicine. For instance, in 2020, the government of Singapore launched the National Precision Medicine (NPM) Strategy to better analyze how phenotypic, genomic, clinical factors and lifestyle factors affect the health of Singapore citizens. Such government initiatives are expected to increase the applications of proteinase K during the forecast period in the region.

Key Players

• Merck KGaA
• Qiagen
• Thermo Fisher Scientific, Inc.
• F. Hoffmann-la Roche Ltd.
• Abcam Plc
• Agilent Technologies, Inc.
• Biocatalysts Ltd.
• Minerva Biolabs GMBH
• Promega Corporation
• Takara Bio, Inc.
• New England Biolabs
• MP Biomedicals

Market Segmentation

• By Form Outlook
• Powder
• Liquid
• By Therapeutic Area Outlook
• Infectious Diseases
• Diabetes
• Oncology
• Cardiology
• Nephrology
• Autoimmune Diseases
• Neurology
• Others
• By Application Outlook
• Isolation and Purification of Genomic DNA & RNA
• In Situ Hybridization
• Mitochondria Isolation
• By End-use Outlook
• Contract Research Organization
• Academic Institutes
• Biotechnology Companies
• Diagnostic Laboratories
• By Regional Outlook
• North America

• U.S.
• Canada
• Europe
• Germany
• U.K.
• France
• Italy
• Spain
• Asia Pacific
• Japan
• China
• India
• Australia
• Singapore
• Latin America
• Brazil
• Mexico
• Argentina
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE